NCT01698541

Brief Summary

Test bioequivalence of generic tacrolimus (Tacni), using original tacrolimus (Prograf) as comparator, in elderly (\>60 yr) renal transplant recipients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

December 3, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

September 21, 2012

Last Update Submit

December 2, 2014

Conditions

End Stage Renal Disease

Keywords

RenalTransplantationElderly

Outcome Measures

Primary Outcomes (1)

  • Bioequivalence

    Bioequivalence will be assessed at steady-state by comparing both AUC(0-12) and Cmax ratios for generic:original-ratios and applying the stricter 90-111% bioequivalence criteria. AUC(0-12) will be assessed by trapezoidal rule and Cmax will be the highest actually measured concentration.

    10 weeks

Secondary Outcomes (1)

  • Population model validation

    10 weeks

Study Arms (2)

Tacni

EXPERIMENTAL

Tacrolimus administered as generic formulation Tacni in accordance with standard protocol at the transplant center

Drug: Tacrolimus

Prograf

ACTIVE COMPARATOR

Tacrolimus administered as Prograf in according to standard protocol at the transplant center

Drug: Tacrolimus

Interventions

TacrolimusDRUG

Tested generic

Also known as: Tacrolimus formualted as the generic Tacni
PrografTacni

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal transplant recipients that will receive Tac as part of their immunosuppressive therapy.
  • Recipients 60 years of age or older.
  • Signed informed consent.

You may not qualify if:

  • Diabetes mellitus (WHO criteria).
  • Concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital, Rikshospitalet

Oslo, 0027, Norway

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Anders Åsberg, PhD

    University of Oslo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2012

First Posted

October 3, 2012

Study Start

February 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

December 3, 2014

Record last verified: 2014-12

Locations

NO(1)